UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007427 |
|---|---|
| Receipt number | R000008724 |
| Scientific Title | A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma. |
| Date of disclosure of the study information | 2012/03/02 |
| Last modified on | 2021/09/08 11:28:34 |
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Basic information
Public title
A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma.
Acronym
A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma.
Scientific Title
A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma.
Scientific Title:Acronym
A prospective co-hort study about efficacy and safety for sorafenib treatment in patients with advanced hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively assess the efficacy and safety in patients with advanced hepatocellular carcinoma treated with sorafenib.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is the overall survival time.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who can expect survival more than three months.
A case of EOCG performance status 0 or 1.
The patient that an effect of the previous treatment, a side effect are not carried over
A case (inspection within two weeks before registration) that enough main organ (including marrow, a heart, the liver, the kidney) functions are maintained.
More than WBC 2000/mm3
More than 8.5 g/dl of Hb
More than Platelet 50,000/mm3
Less than Child-Pugh score seven points
Total bilirubin. 2 mg/dl or less
There not being the abdominal dropsy that Control is impossible of, hepatic encephalopathy
Is less than Creatinine 1.5 mg/dl; or Creatinine Clearance more than 50ml/min
Ejection fraction more than 45% (heart trouble merger patient)
A PaO2 more than 60 mmHg (chronic lung disease patient)
Key exclusion criteria
An infectious disease of the activity (but except the viral hepatitis)
An overlap cancer of the activity
A past of sensitivity to iodocontrast media
A pregnant woman, a nursing girl may be pregnant
The case that the medical attendant judged to be inappropriate as an object of the final examination for reasons of others
(problem cases such as a patient does not hear instructions or the support of the family not being provided)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Nakano |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume
TEL
0942-35-3311
nakano_masahito@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahito |
| Middle name | |
| Last name | Nakano |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume
TEL
0942-35-3311
Homepage URL
nakano_masahito@kurume-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Medicine
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, Department of Medicine
Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine
Address
67 Asahi-machi, Kurume
Tel
0942-35-3311
nakano_masahito@kurume-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observing
Management information
Registered date
| 2012 | Year | 03 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008724
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
